Kornimate/medical-research-clean huggingface dataset:
high-frequency repetitive transcranial magnetic stimulation of the right dorsolateral prefrontal cortex in ptsd

Conditions: PTSD, Post Traumatic Stress Disorder

Summary: the purpose of this study is to compare two slightly different methods of transcranial magnetic stimulation (tms) to treat post traumatic stress disorder (ptsd)

this is a randomized single-blind pilot study investigating the efficacy of high-frequency repetitive transcranial magnetic stimulation (rtms) applied to the right dorsolateral prefrontal cortex at either 10 hz or 20 hz as compared to a treatment as usual group for the treatment of post traumatic stress disorder (ptsd) symptoms.

Eligibility criteria:
inclusion criteria: * willing and able to give informed consent * diagnosis of post-traumatic stress disorder as determined by the scid * caps score of at least 40 * males or females between 18-65 years of age * willing to give up new psychotherapy or changes in psychiatric medications during the course of the tms treatment. exclusion criteria: * current primary axis i disorder including schizophrenia, bipolar disorder type i, major depressive disorder * patients with hdrs score ≥ 18 * a metallic implant in cranium (except the mouth) * patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety * ect treatment within the last three months * patients with a history of epilepsy * patients with neurological disorder leading to increased intracranial pressure * participation in a new course of psychotherapy during the 24 days of the study * a new psychiatric medication within 6 weeks of enrolling in the study * changes in psychiatric medication within 2 weeks of starting the study

Keywords: ptsd, post traumatic stress disorder
magnesium and metabolic syndrome

Conditions: Diabetes Mellitus; High Blood Pressure; Hypomagnesemia

Summary: objective : to test the bp lowering-effect of oral magnesium supplementation, as magnesium chloride (mgcl2) solution, 2.5 g daily, in uncomplicated hypertensive type 2 diabetic subjects with decreased serum magnesium levels design : randomised double blind placebo controlled trial. setting : outpatients with type 2 diabetes from durango, city in northern mexico subjects : 82 subjects between 40 and 75 years of age with type 2 diabetes serum magnesium deficiency and uncomplicated hypertension. interventions : during 4 months the intervention group received 2.5 gr of magnesium chloride (50 ml of a solution containing 50 gr of mgcl2 by 1000 ml of solution ). controls received inert placebo. main outcome measure: change in blood pressure. increase of serum magnesium secondary outcomes measures: changes in lipid profile


Eligibility criteria:
inclusion criteria: * type 2 diabetes * decreased serum magnesium levels * uncomplicated hypertension * 40 and 75 years of age * men and women exclusion criteria: * chronic diarrhea * alcohol intake (equal or more than 30 g per day) * use of diuretics and/or calcium antagonists drugs * previous oral magnesium supplementation * ischemic diseases; and * reduced renal function

Keywords: diabetes hypertension hypomagnesemia
a comparative study of ly900014 with insulin lispro (humalog) in participants with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to evaluate a new formulation of insulin lispro, ly900014, which is a drug that lowers blood sugar. the study will look at how the body processes ly900014, and the effect of ly900014 on blood sugar levels following a standard meal. for each participant, the study will consist of 4 periods and there will be approximately 12 weeks from screening to final study follow up.


Eligibility criteria:
inclusion criteria: * are male or female participants with type 1 diabetes mellitus (t1dm) for at least 1 year * have a body mass index (bmi) of 18.5 kilogram per meter square (kg/m²) to 35.0 kg/m² * have a glycated hemoglobin (hba1c) ≤9.0% at screening * are on stable prandial insulin and basal insulin (neutral protamine hagedorn \[nph\] insulin, insulin glargine or insulin detemir) for at least 3 months before screening with a total insulin dose demand of less than or equal to (≤) 1.5 units per kilogram per day (u/kg/day) exclusion criteria: * are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research * have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study * have donated blood of more than 450 millilitre (ml) or more in the last 3 months or provided any blood donation within the last month before screening. * any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator. * are treated with a csii (insulin pump)
development and evaluation of a self-management model for cancer rehabilitation

Conditions: Head and Neck Cancer; Rehabilitation; Psychotherapy

Summary: participants were primarily recruited from medical institutions, specifically targeting newly diagnosed patients with malignant tumors. they were randomly assigned to two different rehabilitation models using block randomization: the cancer self-help rehabilitation model or the conventional rehabilitation model. during the intervention period, trained oncology advanced practice nurses conducted weekly questionnaire surveys for enrolled patients. during the follow-up period, these surveys were conducted every four weeks. peripheral venous blood samples were collected at baseline and at weeks 0, 4, 8, and 12 after the intervention began to test for biomarkers related to emotional distress.


Eligibility criteria:
inclusion criteria: * pathologically diagnosed with head and neck malignancy. * experiencing psychological distress. * aged between 18 and 70 years. * patients scheduled to receive antitumor treatment in a day hospital or outpatient setting. * ecog performance status score of 0-2. * patients voluntarily participate, fully understand, and are able to independently complete the questionnaires. exclusion criteria: * a history of other malignancies within the past 5 years. * a history of any mental illness, including but not limited to: generalized anxiety disorder, depressive disorder, panic disorder, schizophrenia, or bipolar disorder. * patients currently receiving other psychological treatments or taking psychiatric medications.
a randomized trial comparing oxytocin and oxytocin + ergometrine for prevention of postpartum haemorrhage at caesarean section

Conditions: Prevention of Post Partum Haemorrhage

Summary: this is a randomized trial comparing oxytocin versus oxytocin + syntometrine in the prevention of post partum haemorrhage in patients undergoing caesarean section


Eligibility criteria:
inclusion criteria: * pregnant women delivering by caesarean section older than 18 years willing and able to give informed consent exclusion criteria: * • women not willing or women not able to provide consent * women who have a classical caesarean section * women younger than 18 years of age * women with any of the following conditions will be excluded (ergometrine contra-indicated in patients with these conditions). * pre- eclampsia * eclampsia, * uncontrolled hypertension (hypertension defined as systolic blood pressure more than 140 mm hg and diastolic blood pressure more than 90 mm hg) * any cardiac lesion * impaired liver function * impaired kidney function * hypersensitivity to any of the active ingredients of the preparations that will be used (syntometrine® or syntocinon®) * occlusive vascular disease * autoimmune vasculitis

Keywords: prevention, post partum haemorrhage
hypertension in young adults trial

Conditions: Hypertension

Summary: this is a pilot randomized controlled trial which will test the effect of 3 different anti-hypertensive agents and 3 different strategies of engaging young adults in home blood pressure monitoring on blood pressure control, with secondary outcomes focused on quality of life and adverse events.


Eligibility criteria:
inclusion criteria: * 18-40 years of age * diagnosis of hypertension or receiving anti-hypertensive therapy or has clinical bp readings \>130/80 mmhg that would meet the definition of hypertension and have home bp readings \>=125/80 mmhg exclusion criteria: * are or are planning to become pregnant, due to inability to take multiple classes of anti- hypertensive agents * are marginally housed, due to concerns regarding routine follow-up * are actively participating in a different interventional trial that may affect blood pressure * are unwilling to consent to participate * institutionalized individuals or prisoners * are actively abusing illicit drugs or alcohol * have a history of poor or doubtful compliance (e.g., frequently missed appointments) * have cognitive impairment prohibiting participation in the study * history of allergy to any of the randomized medications * serum potassium \>5.5 meq/l at the screening visit * bp \> 160/100 mmhg in clinic (stage ii hypertension), regardless of whether patient is on therapy * egfr \< 30 ml/min/1.73 m2
agitation in post operative neurosurgical patients

Conditions: Agitation; Craniotomy

Summary: agitation is a significant clinical issue in anesthesiology and critical care medicine. several studies have carried out to survey the epidemics of agitation in post-anesthesia care unit and intensive care unit, and results revealed that agitation had an adverse impact on outcomes. to our clinical experience, agitation can occur in postoperative neurosurgical patients, and is often difficult to manage. however, agitation in this subset of patients is poorly evaluated. in present study, adult patients following craniotomy will be enrolled consecutively, and incidence, risk factor and outcome of emergent agitation will be investigated. the results of the study will provide basic data for prevention and treatment of agitation in postoperative neurosurgical patients.

the study will enroll 120 consecutive adult patients admitted to neuro-icu for post-operative care following craniotomy. sedation-agitation scale (sas) will be evaluated and documented every hour or as needed during stay in icu by nurse on duty. emergent agitation is defined as sas of 5 to 7 at anytime during the first 24 hr of icu stay.patients are divided into 2 groups: non-agitation group (sas 1-4) and agitation group (sas 5-7).data collection includes pre-operative records, events during anesthesia and operation, events during icu stay, and outcomes. the primary outcome is complications such as self-removal of endotracheal tube, central venous or bladder catheters. the secondary and third outcomes are icu stay and glasgow outcome scale at hospital discharge, respectively. incidence of agitation will be calculated to present an epidemiological knowledge. univariate analyses between the two groups will be used for preliminary selection of model variables. then stepwise block logistic regression will be applied to model the risk of agitation using significant univariate predictors.

Eligibility criteria:
inclusion criteria: * adult patients admitted to neuro-icu for post-operative care following craniotomy exclusion criteria: * age\<18 yr old * time interval between operation to icu admission is longer than 24 hr * re-operation within 72 hr * persistently comatose during first 24 hr after operation (gcs≤8)

Keywords: agitation craniotomy incidence risk factor outcome
spectroscopic magnetic resonance imaging of glioma

Conditions: Brain Tumor-Glioma

Summary: the study is designed to develop and test new magnetic resonance imaging methods that can improve the characterization of brain cancer and facilitate improved clinical care of these participants.

the primary objective of this study is to develop and test new magnetic resonance imaging methods that can improve the characterization of brain cancer and facilitate improved clinical care of these participants. more specifically, investigators are interested in applying novel spectroscopic and quantitative mr methods that give information beyond what is produced by a clinical brain mri study and to understand the clinical correlates of the imaging findings. investigators have tested these sequences in healthy volunteers. the investigators now wish to test these sequences in brain cancer participants in order to understand how these sequences can best be applied in a clinical setting. to acquire these data, investigators intend to perform additional mri acquisitions on participants who are scheduled to receive a clinical mri at the umn center for clinical imaging research (ccir), a facility located at the center for magnetic resonance research (cmrr). since these mris are required for the participants' clinical care, the participant will not be making additional visits to the ccir. based on published data and pilot experiences reported from other institutions, the sequences are well-tolerated. the only imposition for the participant is that the participant will spend additional time in the scanner after completion of the imaging required for clinical care. an informed consent form describing the additional mr sequences performed will be presented to the participant.

Eligibility criteria:
inclusion criteria: 1. men and women scheduled who are diagnosed with glioma who is seeking clinical care for their conditions at the umn masonic cancer center. 2. passed the safety screen for mri 3. age 18 or older 4. ability to read and understand english 5. ability to provide informed consent exclusion criteria: 1. participants who are excluded from the base mri scan, as determined by the cmrr/ccir clinical policies are necessarily excluded from this study, as the mri scan will not be performed. 2. pregnant women
improving outcomes in diabetic patients during cabg surgery by optimizing glycemic control

Conditions: Glycemic Control

Summary: this study seeks to determine whether varying the dose of insulin and glucose in diabetic patients during coronary bypass surgery will improve outcomes in these patients.

our previous study has shown that maintaining serum glucose between 120-180mg/dl in the perioperative period during cabg surgery in diabetic patients improves outcomes. the purpose of this trial is: (1) to determine whether outcomes can be improved by altering the content of glucose or insulin in these solutions (2)to determine the effect of these solutions and glycemic control on the inflammatory response of arterial and venous conduits used during surgery, (3) to determine whether the beneficial effects of improved glycemic control can be correlated with changes in the inflammatory response.

Eligibility criteria:
inclusion criteria: * diabetic cabg patients exclusion criteria: * renal and hepatic failure

Keywords: diabetes
influence of hawthorne effect and dual-tasks on gait in cp

Conditions: Cerebral Palsy; Gait Disorders, Neurologic; Hawthorne Effect; Dual-tasks; Kinematics

Summary: it is the clinical experience of the authors that some children with cerebral palsy who walk in crouch gait show sufficient knee extension during the clinical gait analysis, but walk in considerable knee flexion when they leave the gait laboratory. possible differences between walking in a gait lab and walking in daily life may be caused by the effect of observational awareness in the lab (also known as the hawthorne effect), and the lack of dual-tasks (dt) during the analysis (which are common during daily life walking). since so far there is no technique to reliably measure gait kinematics in children with cp outside of the laboratory, the researchers aim to objectify the influence of both the hawthorne effect and dual-tasks by introducing different conditions during a standard clinical 3d gait analysis.

study design: observational study study population: patients with cerebral palsy, bilateral spastic, knee flexion gait pattern, gmfcs classification i-iii, age 4-16 years. objective: to determine the effect of observational awareness (the hawthorne effect) and dual-tasks on spatiotemporal and kinematic variables during a clinical 3d gait analysis. primary research question: does reduced observational awareness and/or introduction of a dual-task influence knee flexion in stance phase in children with spastic diplegie cerebral palsy and knee flexion gait? secondary research questions: 1. does reduced observational awareness and/or introduction of a dual-task increase toe walking in children with spastic diplegie cerebral palsy and knee flexion gait? 2. in children with spastic diplegic cerebral palsy and knee flexion gait, do spatiotemporal gait parameters change when observational awareness is reduced and/or a dual-task is introduced? conditions in which gait data will be gathered: 1. with awareness of observation + without dual-task 2. with awareness of observation + with dual-task 3. without awareness of observation + without dual-task 4. without awareness of observation + with dual-task

Eligibility criteria:
inclusion criteria: * cerebral palsy, bilateral spastic, gmfcs classification i-iii * age \<16 years * use of bilateral afo's (rigid or ground reaction afo's) to improve knee extension in stance exclusion criteria: * behavioural issues or poor instructability which might affect participation in the protocol * significant visual disorders * other diagnoses influencing gait * not willing to sign informed consent before inclusion
long term follow up after 1 year initial lifestyle intervention

Conditions: Obesity

Summary: the effect of non-surgical methods for obesity treatment are not fully documented. this study focus on the long term effect of an intensiv follow up (the "evje model") compared to a regular follow up. the "evje model" is a combined model, consisting of repeated stays at a specialist centre, telephone follow up at home, home groups, self monitoring and close contact with the patients' local physician.

200 patients will undergo a 1 year intensive lifestyle intervention.this group will be randomised into an intervention group (n=100) and a control group (n=100). the intervention group will undergo four years of further follow up in accordance with the intervention model, which means two one weeks stays each year at the evje clinic, telephone follow up, self monitoring and collaboration with the patients' local physician. the control group will be followed up by the patients local physician and a yearly control at the center for morbid obesity at vestfold hospital (sykehuset i vestfold hf). the purpose is to measure the effect of these two follow up models in regard to weight loss maintanance, quality of life and comorbidities.

Eligibility criteria:
inclusion criteria: * patients, referred from public hospitals, with morbid obesity that have undergone one year intensive life style intervention in accordance with the evje model. exclusion criteria: * pregnancy, major and active psychiatric disease, active and serious eating disorder

Keywords: obesity weight loss maintenance qol life style follow up
sternal wound infection in patients undergone sternal fixation using locking compression plates

Conditions: Sternal Fracture; Sternal Wound Infection; Surgical Site Infection

Summary: sternal wound infection (swi) in open heart surgery is one of the most annoying and avoidable complications that one encounters during work. investigators investigate the rates of sternal wound infection (swi) in patients in whom were used locking compression plates (lcp) versus in patients in whom were used wires to fixate the sternum for variable causes. swi increases the overall cost and burden in the medical service and increases the patients suffering and disability. investigators aim to provide our patients with the most suitable means for sternal fixation.


Eligibility criteria:
inclusion criteria: * all genders are accepted * ages from 18 to 80 years old * patients undergoing open heart surgery for any reasons and trauma patients who suffer sternal fractures of any type. exclusion criteria: * ages less than 18 years old and older than 80 years old * patients undergoing minimally invasive surgeries utilizing access sites other than the sternum. * trauma patients with multiple complex injuries.

Keywords: sternum wound infection locking compression plates sternal wires
taxol epirubicin cyclophosphamide herceptin neoadjuvant (techno)

Conditions: Breast Cancer

Summary: the present clinical trial will investigate the safety and efficacy of a sequential preoperative therapy with epirubicin/cyclophosphamide in combination with paclitaxel/trastuzumab, followed by postoperative trastuzumab in patients with her-2 overexpression primary breast cancer.


Eligibility criteria:
inclusion criteria: 1. primary carcinoma of the breast, confirmed histologically by core biopsy (at least 3 core biopsy samples) 2. tumor lesion of the breast with a palpable or a imagistic size ≥ 2 cm or inflammatory breast cancer 3. known her-2 status detected on core biopsy. her-2 over expression is defined as dako herceptest (3+) or dako herceptest (2+) and fish (+) (fluorescence-in-situ-hybridisation). 4. no distant metastatic disease, confirmed by chest x-ray, abdominal sonography and bone scan. 5. female patients 6. age ≥ 18 and ≤ 65 years 7. ecog \< 2/who 0-1 8. laboratory requirements got and bilirubin \ = 3 g/l neutrophile \> 1 g/l thrombocytes \> 100 g/l creatinine (serum) \< 2.0 mg/dl. 9. normal cardiac function, confirmed by cardiologist 10. no active hepatitis 11. written informed consent for all study procedures 12. patients must be available and compliant for treatment and follow-up exclusion criteria: 1. multicentricity in various quadrants (contact the study office) 2. cns-metastases 3. secondary malignancy, excluding basalioma of the skin or carcinoma in situ of the cervix that has received curative therapy 4. patients with relevant hemodynamic cardial diseases 5. patients with a left ventricular ejection fraction (lvef) under the normal limit of the institution, confirmed by echocardiography or muga-scan. 6. uncontrolled, severe comorbidities 7. patients with severe respiratory diseases and severe dyspnea and / or which need supportive oxygen 8. previous anti-her2-therapy 9. patients receiving immunosuppressant therapy 10. known allergy to medication containing cremophor 11. hb \<10 g/dl, neutrophile \<1.5 x109/l, thrombocytes \<100 x109/l. 12. total-serum-bilirubin \>1.5 x uln (upper limit of normal) (except in patients with confirmed and documented gilbert-lereboullet-syndrome), alt or ast \>2.5 x uln (\>5 x uln by liver metastases), alkaline phosphatase \>2.5 x uln (\>4 x uln by liver or bone metastases), serumcreatinine \> 2 x uln 13. pregnancy, nursing (a negative pregnancy test must be documented, and safe anticontraceptive measures during pre- and postoperative treatment must be implemented) 14. lack of signed informed consent after informing the patient 15. lack of willingness to keep and disclose personal medical data as part of the study

Keywords: safety and efficacy of experimental treatment